DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 10/22/2025 have been fully considered but they are not persuasive.
Applicant argues that one of ordinary skill in the art would have had no motivation to combine the Gilson and Fleming prior arts since Gilson discloses a vascular device while Fleming teaches an ear canal plug.
The examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Fleming is considered analogous art to Gilson because the references are in the related field of plugs. Both devices are used to occlude a bodily lumen and are both designed to compress during insertion and expand to contact walls of the bodily lumen to secure the plug in place (see abstract, col. 1 lines 5-10, col. 7 lines 28-31 of Gilson and para. 0009, 0015 of Fleming). Gilson further contemplates numerous geometries to design the plug including a plug having a triangular cross-sectional shape parallel to a vessel axis (see col. 8 lines 16-29 of Gilson) which would result in a cone-shaped plug. Fleming is used as a supporting reference to teach that the shape contemplated by Gilson is known in the art of plugs. The combination of Gilson in view of Fleming would lead one of ordinary skill in the art to the conclusion that when designing a plug for occluding a body lumen, a cone shape is known.
Applicant argues that Fleming fails to teach or suggest “a plurality of discs, each having a flat top side that is positioned towards the first end of the stem, and a convex bottom side that is positioned towards the second end of the stem”.
The examiner respectfully disagrees. Fleming explicitly teaches a plurality of discs 31-34 (Fig. 1, para. 0009), each having a flat top side that is positioned towards a first end of a stem, and a convex bottom side that is positioned towards the second end of the stem (see annotated Fig. 1 of Fleming below). Therefore, the rejection of Gilson in view of Fleming is maintained.
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Annotated Fig. 1 of Fleming
Claim Objections
Claims 4 and 18-20 are objected to because of the following informalities:
Claim 4, line 2: “length” should recite “in length”.
Claim 18, line 4: “said end” should recite “said open end”.
Claim 19, line 1: “the force” should recite “a force”.
Claim 19, line 2: “the force” should recite “a force”.
Claim 20, line 2: “the vessel” should recite “the vascular vessel”.
Claim 20, line 3: “vessel end” should recite “open end.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 7-8, 11, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US 6245090) in view of Fleming (US 20060272649).
Regarding claim 1, Gilson discloses a device 50 (Figs. 17-19) for occluding a vascular vessel having a vessel lumen (col. 1 lines 6-15), the device comprising;
a. a stem 51 having a first end and a second end (see annotated Fig. 17 of Gilson below, col. 7 lines 28-34); and
b. a plurality of discs 52 disposed near the second end of the stem (Fig. 17, col. 7 lines 28-34), wherein the plurality of discs 52 are spaced longitudinally along the stem 51 (Fig. 17, col. 7 lines 28-34),
wherein each disc comprises a top side and a bottom side (see annotated Fig. 17 [A] of Gilson below);
wherein the top side is flat (Figs. 17-18) and positioned towards the first end of the stem 51 (see annotated Figs. 17 and 17 [A] of Gilson below), and the bottom side is positioned towards the second and of the stem 51 (see annotated Figs. 17 and 17 [A] of Gilson below);
wherein each disc has a radius (Fig. 18, col. 7 lines 28-34 discloses that the discs are annular, therefore, have a radius.), wherein the radius of each disc remains the same toward the second end of the stem (Figs. 17-18, col. 7 lines 28-34).
wherein the device is configured to prevent blood flow when inserted into the vessel lumen of the vascular vessel (col. 1 lines 6-15, col. 7 lines 52-55 and lines 61-65).
Gilson further discloses that the implant may be formed into numerous geometries including a shape wherein the cross-sectional shape parallel to the axis is a triangle, which is a form of a cone shape (col. 8 lines 16-29). However, Gilson fails to disclose that the plurality of discs of the embodiment of Figs. 17-19 form a cone shape with the point of the cone at the second end of the stem and the bottom side of each disc is convex.
Fleming in the same field of endeavor of plugs used to occlude a body lumen (Fig. 1, para. 0009) teaches that it is known in the art to configure a plurality of discs 31-34 it forms a cone shape with the point of the cone at the second end of the stem (Figs. 1-2, para. 0009, 0017), wherein the plurality of discs 31-34 (Fig. 1, para. 0009) each have a flat top side that is positioned towards a first end of the stem, and a convex bottom side that is positioned towards the second end of the stem (see annotated Fig. 1 of Fleming below).
It would have been an obvious matter of design choice to modify the plurality of discs in Gilson to be formed in the cone shape as taught by Fleming, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
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Annotated Fig. 17 of Gilson
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Annotated Fig. 17 [A] of Gilson
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Annotated Fig. 1 of Fleming
Regarding claim 2, modified Gilson discloses wherein the stem 51 is cylindrical (Figs. 17-18, col. 7 lines 28-34 of Gilson).
Regarding claim 3, modified Gilson discloses all of the limitations set forth above in claim 1. However, modified Gilson fails to disclose wherein the stem has a radius of about 1.5 mm to 3 mm.
There is no evidence of record that establishes that changing the radius of the stem would result in a difference in function of the modified Gilson stem. Further, a person having ordinary skill in the art, being faced with modifying the radius of the stem of modified Gilson, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed radius dimension which is to prevent blood flow when inserted into the vessel lumen of the vascular vessel (col. 1 lines 6-15, col. 7 lines 52-55 and lines 61-65 of Gilson). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 0034 of the instant application that “the radius of the stem (110; e.g., a cylindrical stem) is about 1.5 mm to 5.5 mm, or about 1.5 mm to 5.0 mm, or about 1.5 mm to 4.5 mm, or about 1.5 mm to 4.0 mm, or about 1.5 mm to 3.5 mm, or about 1.5 mm to 3.0 mm, or about 1.5 mm to 2.5 mm, or about 1.5 mm to 2.0 mm, or about 2.0 mm to 5.5 mm, or about 2.0 mm to 5.0 mm, or about 2.0 mm to 4.5 mm, or about 2.0 mm to 4.0 mm, or about 2.0 mm to 3.5 mm, or about 2.0 mm to 3.0 mm, or about 2.0 mm to 2.5 mm, or about 2.5 mm to 5.5 mm, or about 2.5 mm to 5.0 mm, or about 2.5 mm to 4.5 mm, or about 2.5 mm to 4.0 mm, or about 2.5 mm to 3.5 mm, or about 2.5 mm to 3.0 mm, or about 3.0 mm to 5.5 mm, or about 3.0 mm to 5.0 mm, or about 3.0 mm to 4.5 mm, or about 3.0 mm to 4.0 mm, or about 3.0 mm to 3.5 mm, or about 3.5 mm to 5.5 mm, or about 3.5 mm to 5.0 mm, or about 3.5 mm to 4.5 mm, or about 3.5 mm to 4.0 mm, or about 4.0 mm to 5.5 mm, or about 4.0 mm to 5.0 mm, or about 4.0 mm to 4.5 mm, or about 4.5 mm to 5.5 mm, or about 4.5 mm to 5.0 mm, or about 5.0 mm to 5.5 mm. ”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the radius of the stem of modified Gilson to have a radius in a range of about 1.5 mm to 3 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 4, modified Gilson discloses all of the limitations set forth above in claim 1. However, modified Gilson fails to disclose wherein the stem is about 50 mm to 60 mm length.
There is no evidence of record that establishes that changing the length of the stem would result in a difference in function of the modified Gilson stem. Further, a person having ordinary skill in the art, being faced with modifying the length of the stem of modified Gilson, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length dimension which is to prevent blood flow when inserted into the vessel lumen of the vascular vessel (col. 1 lines 6-15, col. 7 lines 52-55 and lines 61-65 of Gilson). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 0038 of the instant application that “the length of the stem (110) is about 30 mm to 85 mm, or about 30 mm to 80 mm, or about 30 mm to 75 mm, or about 30 mm to 70 mm, or about 30 mm to 65 mm, or about 30 mm to 60 mm, or about 30 mm to 55 mm, or about 30 mm to 50 mm, or about 30 mm to 45 mm, or about 30 mm to 40 mm, or about 30 mm to 35 mm, or about 35 mm to 85 mm, or about 35 mm to 80 mm, or about 35 mm to 75 mm, or about 35 mm to 70 mm, or about 35 mm to 65 mm, or about 35 mm to 60 mm, or about 35 mm to 55 mm, or about 35 mm to 50 mm, or about 35 mm to 45 mm, or about 35 mm to 40 mm, or about 40 mm to 85 mm, or about 40 mm to 80 mm, or about 40 mm to 75 mm, or about 40 mm to 70 mm, or about 40 mm to 65 mm, or about 40 mm to 60 mm, or about 40 mm to 55 mm, or about 40 mm to 50 mm, or about 40 mm to 45 mm, or about 45 mm to 85 mm, or about 45 mm to 80 mm, or about 45 mm to 75 mm, or about 45 mm to 70 mm, or about 45 mm to 65 mm, or about 45 mm to 60 mm, or about 45 mm to 55 mm, or about 45 mm to 50 mm, or about 50 mm to 85 mm, or about 50 mm to 80 mm, or about 50 mm to 75 mm, or about 50 mm to 70 mm, or about 50 mm to 65 mm, or about 50 mm to 60 mm, or about 50 mm to 55 mm, or about 55 mm to 85 mm, or about 55 mm to 80 mm, or about 55 mm to 75 mm, or about 55 mm to 70 mm, or about 55 mm to 65 mm, or about 55 mm to 60 mm, or about 60 mm to 85 mm, or about 60 mm to 80 mm, or about 60 mm to 75 mm, or about 60 mm to 70 mm, or about 60 mm to 65 mm, or about 65 mm to 85 mm, or about 65 mm to 80 mm, or about 65 mm to 75 mm, or about 65 mm to 70 mm, or about 70 mm to 85 mm, or about 70 mm to 80 mm, or about 70 mm to 75 mm, or about 75 mm to 85 mm, or about 75 mm to 80 mm, or about 80 mm to 85 mm. ”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the stem of modified Gilson to have a length in a range of about 50 mm to 60 mm as an obvious matter of design choice within the skill of the art.
Regarding claims 7 and 8, modified Gilson discloses all of the limitations set forth above in claim 1. However, Gilson fails to disclose wherein the plurality of discs have diameters ranging from 0.5 mm to 15 mm (claim 7)/ 1 mm to 10 mm (claim 8).
There is no evidence of record that establishes that changing the diameters of the plurality of discs would result in a difference in function of the modified Gilson plurality of discs. Further, a person having ordinary skill in the art, being faced with modifying the diameters of the plurality of discs of modified Gilson, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter dimensions which is to prevent blood flow when inserted into the vessel lumen of the vascular vessel (col. 1 lines 6-15, col. 7 lines 52-55 and lines 61-65 of Gilson). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 0034 of the instant application that “the diameter of the plurality of discs (120) ranges from about 0.5 mm to 15 mm, or about 0.5 mm to 12 mm, or about 0.5 mm to 10 mm, or about 0.5 mm to 8 mm, or about 0.5 mm to 7.5 mm, or about 0.5 mm to 7.0 mm, or about 0.5 mm to 6.0 mm, or about 0.5 mm to 5.0 mm, or about 0.5 mm to 4.0 mm, or about 0.5 mm to 3.0 mm or about 0.5 mm to 2.0 mm, or about 0.5 mm to 1.0 mm, or about 1.0 mm to 15 mm, or about 1.0 mm to 12 mm, or about 1.0 mm to 10 mm, or about 1.0 mm to 8 mm, or about 1.0 mm to 7.5 mm, or about 1.0 mm to 7.0 mm, or about 1.0 mm to 6.0 mm, or about 1.0 mm to 5.0 mm, or about 1.0 mm to 4.0 mm, or about 1.0 mm to 3.0 mm or about 1.0 mm to 2.0 mm, or about 2.0 mm to 15 mm, or about 2.0 mm to 12 mm, or about 2.0 mm to 10 mm, or about 2.0 mm to 8 mm, or about 2.0 mm to 7.5 mm, or about 2.0 mm to 7.0 mm, or about 2.0 mm to 6.0 mm, or about 2.0 mm to 5.0 mm, or about 2.0 mm to 4.0 mm, or about 1.0 mm to 3.0 mm or about 3.0 mm to 15 mm, or about 3.0 mm to 12 mm, or about 3.0 mm to 10 mm, or about 3.0 mm to 8 mm, or about 3.0 mm to 7.5 mm, or about 3.0 mm to 7.0 mm, or about 3.0 mm to 6.0 mm, or about 3.0 mm to 5.0 mm, or about 3.0 mm to 4.0 mm, or about 4.0 mm to 15 mm, or about 4.0 mm to 12 mm, or about 4.0 mm to 10 mm, or about 4.0 mm to 8 mm, or about 4.0 mm to 7.5 mm, or about 4.0 mm to 7.0 mm, or about 4.0 mm to 6.0 mm, or about 4.0 mm to 5.0 mm, or about 5.0 mm to 15 mm, or about 5.0 mm to 12 mm, or about 5.0 mm to 10 mm, or about 5.0 mm to 8 mm, or about 5.0 mm to 7.5 mm, or about 5.0 mm to 7.0 mm, or about 5.0 mm to 6.0 mm, or about 6.0 mm to 15 mm, or about 6.0 mm to 12 mm, or about 6.0 mm to 10 mm, or about 6.0 mm to 8 mm, or about 6.0 mm to 7.5 mm, or about 6.0 mm to 7.0 mm, or about 7.0 mm to 15 mm, or about 7.0 mm to 12 mm, or about 7.0 mm to 10 mm, or about 7.0 mm to 8 mm, or about 7.0 mm to 7.5 mm, or about 7.5 mm to 15 mm, or about 7.5 mm to 12 mm, or about 7.5 mm to 10 mm, or about 7.5 mm to 8 mm, or about 8.0 mm to 15 mm, or about 8.0 mm to 12 mm, or about 8.0 mm to 10 mm, or about 10 mm to 15 mm, or about 10 mm to 12 mm, or about 12 mm to 15 mm.”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameters of the plurality of discs of modified Gilson to be within a range of a 0.5 mm to 15 mm (claim 7)/ 1 mm to 10 mm (claim 8) as an obvious matter of design choice within the skill of the art.
Regarding claim 11, modified Gilson discloses wherein an outer edge of each disc 52 is convex and smooth (Fig. 18 of Gilson).
Regarding claim 14, modified Gilson discloses wherein the plurality of discs 52 are stationary on the stem (Figs. 17-18, col. 7 lines 28-34 of Gilson).
Regarding claim 15, modified Gilson discloses all of the limitations set forth above in claim 1. However, modified Gilson fails to disclose wherein the plurality of discs are spaced about 1.0 mm to 1.5 mm apart.
There is no evidence of record that establishes that changing the space between the plurality of discs would result in a difference in function of the modified Gilson discs. Further, a person having ordinary skill in the art, being faced with modifying the space between the plurality of discs of modified Gilson, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length dimension which is to prevent blood flow when inserted into the vessel lumen of the vascular vessel (col. 1 lines 6-15, col. 7 lines 52-55 and lines 61-65 of Gilson). Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating in para. 0051 of the instant application that “the plurality of discs (120) are separated by about 2 mm, or about 1.75 mm, or about 1.5 mm, or about 1.25 mm, or about 1.0 mm, or about 0.75 mm, or about 0.5 mm. In some embodiments, the plurality of discs (120) are separated by about 0.5 mm to 2 mm, or about 0.5 mm to 1.75 mm, or about 0.5 mm to 1.5 mm or about 0.5 mm to 1.25 mm, or about 0.5 mm to 1.0 mm or about 0.5 mm to 0.75 mm, or about 0.75 mm to 2 mm, or about 0.75 mm to 1.75 mm, or about 0.75 mm to 1.5 mm or about 0.75 mm to 1.25 mm, or about 0.75 mm to 1.0 mm, or about 1.0 mm to 2 mm, or about 1.0 mm to 1.75 mm, or about 1.0 mm to 1.5 mm or about 1.0 mm to 1.25 mm, or about 1.25 mm to 2 mm, or about 1.25 mm to 1.75 mm, or about 1.25 mm to 1.5 mm, or about 1.5 mm to 2 mm, or about 1.5 mm to 1.75 mm, or about 1.75 mm to 2 mm”. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of discs of modified Gilson to be spaced apart within a range from about 1.0 mm to 1.5 mm as an obvious matter of design choice within the skill of the art.
Regarding claim 16, modified Gilson discloses wherein the device is made from medical grade silicon (col. 2 lines 51-52, col. 9 lines 14-24 of Gilson).
Regarding claim 17, modified Gilson discloses wherein the device is a monolithic device (Figs. 17-19, col. 8 lines 39-47 and col. 9 lines 25-30 of Gilson).
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US 6245090) in view of Fleming (US 20060272649) as applied to claim 1 above, and further in view of Smith (US 20070116309).
Regarding claims 5 and 6, modified Gilson discloses wherein the device comprises 4 discs (Figs. 1-2, para. 0009, 0017). However, modified Gilson fails to disclose the device comprising 6 discs (claim 5)/ 5 discs (claim 6).
Smith in the same field of endeavor of plug devices used to occlude a body lumen (Figs. 12-13, para. 0042, 0045, 0082-0083), wherein the device comprises 6 discs (claim 5)/ 5 discs (claim 6) (para. 0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the device in modified Gilson to include 6 discs (claim 5)/ 5 discs (claim 6) as taught by Smith in order to better secure the device in the vessel (para. 0082 of Smith).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US 6245090) in view of Fleming (US 20060272649) as applied to claim 1 above, and further in view of Tsugita et al. (US 6080183) [hereinafter Tsugita].
Regarding claim 12, modified Gilson discloses all of the limitations set forth above in claim 1. However, modified Gilson fails to disclose wherein the top side of the plurality of discs is more rigid than the bottom side of the plurality of discs.
Tsugita in the same field of endeavor of plugs used to occlude a body lumen (Fig. 1, col. 3 lines 39-49) teaches that it is known in the art to have a top side of a disc (interpreted as the stiff top side of flange 12, see embodiment Fig. 6F, col. 4 lines 28-34) be more rigid than a bottom side of the disc (interpreted as the soft bottom side of flange 12, see embodiment Fig. 6F, col. 4 lines 28-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the top and bottom sides of the plurality of discs in modified Gilson to include the stiff top side and soft bottom side, as taught by Tsugita, in order to allow the top side to provide structural support to the discs when positioned within the body lumen and allow the bottom side to provide a flexibility to the discs to conform to the body lumen, thereby allowing better contact between the flange and the vessel wall (col. 4 lines 29-32 of Tsugita).
Regarding claim 13, modified Gilson discloses all of the limitations set forth above in claim 1. However, modified Gilson fails to disclose wherein the plurality of discs are more flexible when force is applied from the bottom side towards the top side of the discs.
Tsugita in the same field of endeavor of plugs used to occlude a body lumen (Fig. 1, col. 3 lines 39-49) teaches that it is known in the art to have a top side of a disc (interpreted as the stiff top side of flange 12, see embodiment Fig. 6F, col. 4 lines 28-34) be more rigid than a bottom side of the disc (interpreted as the soft bottom side of flange 12, see embodiment Fig. 6F, col. 4 lines 28-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the top and bottom sides of the plurality of discs in modified Gilson to include the stiff top side and soft bottom side, as taught by Tsugita, in order to allow the top side to provide structural support to the discs when positioned within the body lumen and allow the bottom side to provide a flexibility to the discs to conform to the body lumen, thereby allowing better contact between the flange and the vessel wall (col. 4 lines 29-32 of Tsugita).
The combination of modified Gilson in view of Tsugita would result in a product wherein the plurality of discs 52 of Gilson (Fig. 17, col. 7 lines 28-34) are more flexible when force is applied from the bottom side towards the top side of the discs, due to the bottom side of the discs being formed of a more flexible material than the top side of the discs as taught by Tsugita (col. 4 lines 29-32).
Claim(s) 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gilson et al. (US 6245090) in view of Fleming (US 20060272649) as applied to claim 1 above, and further in view of Ravikumar et al. (US 20050125022) [hereinafter Ravikumar].
Regarding claim 18, modified Gilson discloses a method of occluding a vascular vessel having a vessel lumen (col. 1 lines 6-15, col. 7 lines 52-55 and lines 61-65 of Gilson), the method comprising inserting a device according to any one of claim 1 (Figs. 17-19, col. 9 lines 25-30 of Gilson) into the lumen of a vessel (Figs. 17-19, abstract; col. 9 lines 25-30 of Gilson).
However, the method of modified Gilson fails to disclose wherein the vessel has an open end into which at least one of the discs is inserted therein, thereby plugging said end.
Ravikumar in the same field of endeavor of plug devices used to occlude a vascular vessel having a vessel lumen (Fig. 1, 0031, 0034) teaches that it is known in the art to use a plug device 102 to insert the plug 102 into the lumen 106 of the vessel 104, wherein the vessel 104 has an open end into which the plug 102 is inserted therein (Fig. 1, para. 0036), thereby plugging said end (Fig. 1, para. 0031, 0036) for treating abdominal aortic aneurysms (AAA) (para. 0020, 0038).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique i.e. inserting the plug device in an open end of the vessel as taught by Ravikumar to the method of modified Gilson would have yielded predicable results, namely a way to increase the utility of the plug device of modified Gilson such that at least one of the discs are inserted within the open end of the vessel to inhibit blood flow (para. 0020, 0031, 0038 of Ravikumar).
Regarding claim 19, modified Gilson discloses wherein the force needed to insert the device is less than the force needed to remove the device (Gilson discloses that the device is compressed to a very small size during insertion and expands to a relatively large diameter such that the device expands against the vessel lumen (abstract, col. 4 lines 58-67 and col. 5 lines 1-5). Therefore, the force needed to insert the device is less than the force needed to remove the device due to the transition in size).
Regarding claim 20, modified Gilson discloses wherein the device inserted into the vessel lumen exerts a radial force on the vessel to prevent blood from flowing out of the plugged vessel end (col. 3 lines 17-28 and col. 6 lines 43-51 of Gilson).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771